An international core outcome set for evaluating interventions to improve informed consent to clinical trials: The ELICIT Study

Gillies, Katie, Williamson, Paula R ORCID: 0000-0001-9802-6636, Entwistle, Vikki A, Gardner, Heidi, Treweek, Shaun and Campbell, Marion K (2021) An international core outcome set for evaluating interventions to improve informed consent to clinical trials: The ELICIT Study. JOURNAL OF CLINICAL EPIDEMIOLOGY, 137. pp. 14-22.

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Official URL: http://dx.doi.org/10.1016/j.jclinepi.2021.02.020

Abstract

<h4>Objective</h4>To develop a core outcome set for the evaluation of interventions that aim to improve how people make decisions about whether to participate in randomized controlled trials (of healthcare interventions), the ELICIT Study.<h4>Study design</h4>International mixed-method study involving a systematic review of existing outcomes, semi-structured interviews, an online Delphi survey, and a face-to-face consensus meeting.<h4>Results</h4>The literature review and stakeholder interviews (n = 25) initially identified 1045 reported outcomes that were grouped into 40 individually distinct outcomes. These 40 outcomes were scored for importance in two rounds of an online Delphi survey (n = 79), with 18 people attending the consensus meeting. Consensus was reached on 12 core outcomes: therapeutic misconception; comfort with decision; authenticity of decision; communication about the trial; empowerment; sense of altruism; equipoise; knowledge; salience of questions; understanding, how helpful the process was for decision making; and trial attrition.<h4>Conclusion</h4>The ELICIT core outcome set is the first internationally agreed minimum set of outcomes deemed essential to be measured in all future studies evaluating interventions to improve decisions about participating in an randomized controlled trial. Use of the ELICIT core set will ensure that results from these trials are comparable and relevant to all stakeholders.<h4>Registration</h4>COMET database - http://www.comet-initiative.org/Studies/Details/595.

Item Type:	Article
Uncontrolled Keywords:	informed consent, decision making, clinical trials, core outcome sets, methodology, research waste
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health Faculty of Science and Engineering > School of Environmental Sciences
Depositing User:	Symplectic Admin
Date Deposited:	11 May 2021 10:05
Last Modified:	18 Jan 2023 22:47
DOI:	10.1016/j.jclinepi.2021.02.020
Open Access URL:	https://doi.org/10.1016/j.jclinepi.2021.02.020
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3122317